Negative Pressure Suction for Oropharyngeal Dysphagia

Overseen By Randev Sandhu, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Complete PES stricture, Malignant disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an investigator initiated prospective study to determine whether the use of a negative pressure suction in the hypopharynx will reduce the amount of aspiration during Video Fluoroscopic Swallowing Exam (VFSE) among patients with oropharyngeal dysphagia.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Negative Pressure Suction Catheter for oropharyngeal dysphagia?

Research using a similar suction catheter in a model of severe swallowing difficulties showed that using negative pressure suction significantly reduced the risk of aspiration (food or liquid entering the airway) from 100% to 0%, indicating it may be effective in preventing aspiration in oropharyngeal dysphagia. ^{1 2 3 4 5}

Is negative pressure suction safe for humans?

Negative pressure suction has been used in various medical settings, such as clearing airways in infants and assisting choking victims, with minimal reported risks. In a study using a cadaver model, it effectively reduced aspiration without adverse effects, suggesting it may be generally safe. ^{1 6 7 8 9}

How does the Negative Pressure Suction Catheter treatment for oropharyngeal dysphagia differ from other treatments?

The Negative Pressure Suction Catheter treatment is unique because it uses suction to prevent aspiration (inhaling food or liquid into the lungs) by applying negative pressure at the upper esophageal sphincter, which significantly reduces the risk of aspiration compared to no treatment. ^{1 5 6 7 10}

Eligibility Criteria

This trial is for patients with oropharyngeal dysphagia who have a high risk of food entering their airway, rely on tube feeding, and haven't improved with standard treatments. It's not for those with severe throat narrowing, cognitive issues preventing cooperation, active cancer, no feeding tube, or recent cancer survivors.

Inclusion Criteria

Patients with videofluoroscopic evidence of aspiration with Rosenbek Penetration Aspiration Scale (PAS) greater than 5 for all tested food consistencies

You rely on a feeding tube that goes through your stomach.

You have tried all standard treatment options, including physical therapy, medication, and surgery.

Exclusion Criteria

No gastrostomy tube present

Inability to follow commands

Vulnerable populations: adults unable to consent, pregnant women, and prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Video Fluoroscopic Swallowing Exam (VFSE) with the use of a negative pressure suction device to reduce aspiration

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the VFSE treatment

4 weeks

Treatment Details

Interventions

• Negative Pressure Suction Catheter

Trial Overview The study tests if using a negative pressure suction catheter in the throat can reduce aspiration (food going into the lungs) during swallowing exams in people with difficulty swallowing.

Participant Groups

Group I: Negative Pressure Suction Device Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Findings from Research

The LifeVac, a novel portable non-powered suction device, has been reported to successfully resuscitate 38 out of 39 adults with oropharyngeal dysphagia during choking emergencies over a 6-year period, indicating its potential efficacy in real-world situations.

The device presents a minimal risk and may serve as a valuable alternative for resuscitating choking patients when traditional methods like abdominal thrusts or back blows are ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Novel Portable Non-powered Suction Device in Patients With Oropharyngeal Dysphagia During a Choking Emergency. McKinley, MJ., Deede, J., Markowitz, B.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of hypopharyngeal suction to eliminate aspiration: the Retro-Esophageal Suction (REScue) catheter. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of oral and pharyngeal dysphagia. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

Identification of risk groups for oropharyngeal dysphagia in hospitalized patients in a university hospital. [2014]

4. Spain pubmed.ncbi.nlm.nih.gov

[Treatment of oropharyngeal dysphagia with neuromuscular electrostimulaiton]. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Identification of a know-do gap: An observational study of the assessment and treatment of dysphagia during inpatient stroke rehabilitation in primary healthcare in Norway. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Impact of deep oropharyngeal suctioning on microaspiration, ventilator events, and clinical outcomes: A randomized clinical trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Routine oro/nasopharyngeal suction versus no suction at birth. [2023]

8. Sweden pubmed.ncbi.nlm.nih.gov

Nutritional assessment and post-procedural complications in older stroke patients after insertion of percutaneous endoscopic gastrostomy - a retrospective study. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Use of a Novel Portable Non-powered Suction Device in Patients With Oropharyngeal Dysphagia During a Choking Emergency. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Oropharyngeal dysphagia in head and neck cancer: how to reduce aspiration pneumonia. [2023]